FDA.reportPublic FDA data

Cardiac sizing catheter

Definition
A sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.
GUDID devices
63
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05051223003984Universal CannulaPURPLE SURGICAL INTERNATIONAL LIMITEDPS35062016-09-17
14026704658777HUDSON RCITELEFLEX INCORPORATEDIPN0297182019-09-25
14026704658784HUDSON RCITELEFLEX INCORPORATEDIPN0297192019-09-25
14026704658791HUDSON RCITELEFLEX INCORPORATEDIPN0297202019-09-25
14026704717702HUDSON RCITELEFLEX INCORPORATEDIPN9166752021-01-22
04046964310911PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137002016-08-09
04046964310935PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137012016-08-09
04046964310959PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137022016-08-09
04046964310973PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137032016-08-09
04046964310997PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137042016-08-09
04046964311017PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137052016-08-09
04046964311031PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137062016-08-09
04046964311055PTS®B BRAUN INTERVENTIONAL SYSTEMS, INC6137072016-08-09
04046964511981PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137322016-08-09
04046964512025PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137362016-08-09
04046964512049PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137382016-08-09
04046964512056PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137392016-08-09
04046964512063PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137402016-08-09
04046964512087PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137422016-08-09
04046964512094PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137432016-08-09
04046964512100PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137442016-08-09
04046964512124PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137462016-08-09
04046964512148PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137482016-08-09
04046964512155PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137492016-08-09
04046964512179PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137512016-08-09
04046964512001PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137342016-08-09
04046964512117PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137452016-08-09
04046964511967PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137302016-08-09
04046964511974PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137312016-08-09
04046964511998PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137332016-08-09
04046964512018PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137352016-08-09
04046964512032PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137372016-08-09
04046964512070PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137412016-08-09
04046964512131PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137472016-08-09
04046964512162PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137502016-08-09
04046964512186PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137522016-08-09
04046955677269PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137182021-02-19
04046955677221PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137162021-02-13
04046955677245PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137172021-02-13
04046955677283PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137192021-02-13
04046955677306PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137202021-02-13
04046955677320PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137212021-02-13
04046955677344PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137222021-02-13
04046955677368PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137232021-02-13
04046955677382PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137242021-02-13
04046955677405PTS-X™B BRAUN INTERVENTIONAL SYSTEMS, INC6137252021-02-13
24026704717709HUDSON RCITELEFLEX INCORPORATEDIPN9166752021-01-22
00836559006909Venos Occlusion Balloon CatheterOscor Inc.V0580102017-11-30
00836559006916Venos Occlusion Balloon CatheterOscor Inc.V05100102017-11-30
00836559006923Venos Occlusion Balloon CatheterOscor Inc.V0680102017-11-30
00836559006930Venos Occlusion Balloon CatheterOscor Inc.V06100102017-11-30
00836559007074Venos Occlusion Balloon CatheterOscor Inc.V0580152017-11-30
00836559007081Venos Occlusion Balloon CatheterOscor Inc.V05100152017-11-30
00836559007098Venos Occlusion Balloon CatheterOscor Inc.V0680152017-11-30
00836559007104Venos Occlusion Balloon CatheterOscor Inc.V06100152017-11-30
00836559007111Venos Occlusion Balloon CatheterOscor Inc.V06120152017-11-30
24026704658774HUDSON RCITELEFLEX INCORPORATEDIPN0297182019-09-25
24026704658781HUDSON RCITELEFLEX INCORPORATEDIPN0297192019-09-25
24026704658798HUDSON RCITELEFLEX INCORPORATEDIPN0297202019-09-25
50551223003989Universal CannulaPURPLE SURGICAL INTERNATIONAL LIMITEDPS35062016-09-17
00811806011516Amplatzer™ST. JUDE MEDICAL, INC.9-SB-0182016-01-15
00811806011523Amplatzer™ST. JUDE MEDICAL, INC.9-SB-0242016-01-15
00811806011530Amplatzer™ST. JUDE MEDICAL, INC.9-SB-0342016-01-15